1. Field of the Invention
This invention relates to a non-ambulatory thermotherapy device comprising a thermal pad and an enclosure containing the thermal pad. The thermal pad consists of solid, pliable gel and bumps disposed throughout the entire surface of the thermal gel pad. One embodiment of the thermotherapy device is a Thermo Therapy Boot (marketed under the trademark THERMABOOT®) comprising two (2) thermal gel pads, one pad for the sole of the boot, and one pad for the body of the boot. When the two pads are sewn in their respective enclosures, the enclosures are then sewn together to form the finished boot. Specifically, the bumps are raised protuberances or nodules emanating from the gel pad itself. Therefore, the gel pad and the bumps or nodules (marketed under the trademark THERMABUMP®) are one in the same unit. The bumps or nodules are designed to help improve the surface contact with the irregularly shaped boney contours which naturally occur anatomically along the foot and ankle complex.
One model of the thermotherapy device is a boot (thermotherapy boot) designed to fit either left or right foot/ankle complex. The thermotherapy boot is manufactured in two or more sizes.
Another embodiment of the thermotherapy device is a glove (thermotherapy glove) that is designed to be used on either the left or right hand/wrist complex. The thermotherapy glove is made in a variety of sizes, also excluding the structural considerations that would be necessary for gloves which are worn for work or for one's personal attire. The thermotherapy glove continues 3″ to 4″ above the wrist and is secured with one VELCRO® (hook and loop fastener) strap around the distal end of the glove. The thermotherapy glove may also be designed with a second strap around the dorsal/palmar aspect of the hand. Smaller straps that are located over the knuckles or finger joints are also a considered a design of this embodiment. The thermotherapy glove also uses the THERMABUMP® design to improve surface contact between the irregularly shaped contours of the hand/wrist complex, as well as the fingers. The thermotherapy glove is used as opposed to a mitt design (prior art) in order to provide separate finger compartments for improved individualized treatment of finger injuries. The collateral swelling and soreness that normally accompany most musculoskeletal injuries will receive treatment as well as the injury site itself. The THERMABUMP® design of the thermotherapy device (boot and glove) may also be modified in shape and size for use in veterinary medicine, where heat and cold therapy is required and appropriate.
2. Background Information
The most prevalent conditions seen in podiatric practice are heel pain/plantar fasciitis, foot injury, arthritis of toes, flat fleet or fallen arches, bone spurs, hammertoes, warts or infection. A large number of these conditions require as part of the treatment regimen application of hot/cold therapy. Currently, it is extremely difficult for an individual in need of hot or cold treatment to the foot to find a thermal boot that would be suitable for effectively reducing swelling or pain to reduce inflammation and/or induce healing. The devices currently sold on the market and described in prior art, such as the gel filled mitt for hand injuries or the bead filled boot for heat therapy have several disadvantages, for example, they are unsuitable for creating temperature changes rapidly and for prolonged periods, to provide relief or they are unsuitable to be applied to hard to reach affected areas.
There is need for a thermal boot device that can effectively apply heat or cold treatments throughout the foot and/or the affected part of the foot. Hot and cold therapy devices have been subject of earlier patents, for example, U.S. Pat. No. 5,027,801, issued to Grim, discloses an orthopedic gel pad assembly including a layer of gel, a backing layer extending across the rear of the gel, and an orthopedic support means for holding the gel pad assembly against the injured body part of the user. This gel assembly is weight bearing and would not be suitable for use in the foot because in the foot, the gel pad would be bulky and difficult to keep in place, and the thermal pad would not reach difficult to reach structures in the foot.
U.S. Pat. No. 5,921,243 issued to Shakoor, describes a device for applying heat or cold therapy to a human foot having a plantar and a dorsum. The device is made of a flexible material that can wrap around the plantar and the dorsum of the foot, and the device has one pouch filled with a liquid located in the plantar region and a second liquid filled pouch located in the dorsum. The liquid in each of the pouches is used to apply heat or cold to the foot. Shakoor does not describe or suggest in any way that the liquid should be filled in a plurality of bumps, nipples or mini-pouches. The disadvantages of the Shakoor device are that liquid filled pouches in flexible material do not reach the toes, and the flat liquid filled pouches do not engage or come into contact with curves of the foot caused by bony protuberances of irregularly shaped bones in the foot such as navicular and metatarsal heads. This creates the problem of inadequate heat or cold exchange.
U.S. Pat. No. 3,595,244 issued to Kugler describes a foot-massaging sandal of flexible construction so that the toe portion may bend during walking, and the foot-contacting surface has irregularly disposed ridges which effect massaging action on the plantar surface of the foot. The disadvantage of this device is that it is constructed for massaging using ridges of various widths, heights and spacing but are solid and made of polyvinyl chloride or polyethylene.
Moreover, the device is designed so that the ridges cannot be placed over the first and fifth metatarsal heads to avoid painful massage of corns and calluses. Thus this device teaches away from the use of ridges or thermal bumps all over the foot region, or other areas in need for hot or cold therapy.
U.S. Pat. No. 5,607,749 issued to Strumor describes an acupressure massaging system including an array of spaced flexible and collapsible nipples extending vertically from the upper surface of a platform. The platform has air flow and air channels. The nipples have a collapsible accordion type structure, so that compression and movement of nipples creates a re-circulation or airflow effect through air flow channels and air flow holes to prevent suction and promote free movement of the nipples to exert an acupressure massaging counterforce on contacting surfaces.
There are other devices currently sold on the market, for example, the gel filled mitt used for hand injuries (having no thermal bumps but a smooth surface) and a boot for heat therapy, using beads to retain heat. However, these models also suffer from some of the disadvantages described above.
Accordingly, the present invention overcomes the aforementioned disadvantages and is directed to a thermotherapy device having a plurality of thermal bumps designed to enable improved penetration of heat or cold to bring relief to areas requiring treatment (treatment area). The invention provides specific products suitable for hot/cold therapy of foot conditions, as well as products that are developed for applying heat/cold therapy to the elbow, knee, ankle, neck, hand, wrist, shoulder, back, lumbar region, sinuses, temporo mandibular joint, head and pressure point areas where bed sores develop.
Many foot and ankle conditions such as sprains; strains; plantar fascitis; post surgical and certain fractures which are treated by rehabilitation professionals and physicians will, at some point, require heat and/or cold therapy as part of their rehabilitation protocol. The thermotherapy device of the present invention is not only appropriate for professional clinics, it is also easy and convenient enough for an individual to use at home.
Circulation is most difficult to and from the distal areas of the extremities. In this case, the foot and ankle or the hands and wrists. A boot is necessary for heat/cold therapy when treating ankle/foot injuries for two basic reasons:                (1) Swelling and inflammation will encompass healthy tissues collateral to the injury site; therefore, coverage of the foot/ankle complex, completely, ensures a superior heat cold therapy treatment; and        (2) As mentioned earlier, the foot and ankle are the most difficult areas of the human body to deliver blood to, and remove metabolites (waste products) from. Keep in mind, blood carrying nutrients and oxygen are an important part of the healing process. The boot and glove designs of the present invention provide necessary and very effective means of promoting circulation through heat/cold therapy. Another convenience and an important consideration of the thermotherapy device of the invention is that the boot is designed so that one boot can be used on either the left or right foot and ankle.        
The thermotherapy device of the present invention optionally requires a means of fastening. In the thermotherapy boot, there are three adjustable VELCRO® fasteners (as defined herein): one around the ankle; one at the forefoot; and one at the proximal aspect of the toes (metatarsal/phalangeal/joints). The straps are used only to provide the wearer with a snugger or looser surface contact between the foot and ankle against the boot. The forefoot and metatarsal straps hook or fasten on the outside, or bottom of the boot. This is designed as a built-in reminder to the wearer that thermotherapy boot is not designed or intended for walking, weight bearing, or any type of shock absorption. A person with a fracture or post-surgical situation should not weight bear, as this may disrupt the healing process.
The thermotherapy device of the present invention is designed for heat or cold therapy. This is better demonstrated through two illustrations included with this application. A person receiving heat/or cold therapy to the foot/ankle will either lie down with the affected leg raised just above the heart line, or seated comfortably. A reclined or semi-reclined position will best promote both lymphatic and blood circulation.
Since the thermotherapy device of the present invention does not use sealed chambers with liquids encapsulated within, there is no chance of leaking or drying up. The thermotherapy device can continue to function even if it is torn. Thus, it adds a very important cost-effective feature to the device.
Although there are existing Square Packs as well as specialty shaped heat/cold packs that are available, as stated earlier, it is important to cover the entire foot/ankle complex when treating the area with heat/cold therapies. The thermotherapy device of the present invention provides consistent applications through complete coverage of the areas every time it is used: covering only part of these areas is not thorough enough. For this reason, there is a need for a thermotherapy boot that can effectively apply heat or cold treatments to the foot/ankle complex.
Heat and cold therapy devices, amongst other embodiments, have been the subjects of earlier patents: (U.S. Pat. No. 5,921,243 Shakour); (U.S. Pat. No. 5,027,801—Grim). Grim's is a weight-bearing device. Shakour's device uses liquid pouches that can't match the more cost effective method used by the thermotherapy device of the present invention. Other embodiments include: (U.S. Pat. No. 3,595,244—Kugler) which is a foot massaging sandal; (U.S. Pat. No. 5,607,749—Strumor) an acupressure massaging system, both come in pairs and are for walking and designed with shock absorption. In summary, while these devices are fine, they teach an entirely different art and focus on entirely different matters.
In addition, (U.S. Pat. No. 5,551,173—Chambers)—Chambers' device is reversible insole with a reflexology chart included. U.S. Pat. No. 4,471,538—Pomeranz, is a shock absorbing device using Rheopexic fluid. U.S. Pat. No. 5,553,399 is another art that teaches shock absorption as well as depending on one's own body heat to protect against cold weather conditions.
None of the above-mentioned devices in the prior art claim therapeutic temperature retaining properties. In addition, these applications involve only body heat exchange. They teach ambulation and shock absorption using Rheopexic fluid.
In contrast, the thermotherapy device of the present invention exhibits heat and cold retaining properties, as well as defines the parameters of heat and cold therapy in order to further substantiate the validity of this device. With regard to heating or cooling, the thermotherapy device of the present invention will remain soft and pliable even in temperatures as low as −20° F. Many other devices for heat and cold therapy will become stiff and or brittle when left in a freezer for a prolonged period of time. This characteristic would not be appropriate or comfortable for this very specific application and use. The thermotherapy device of the present invention can be prepared to provide 20 to 30 minutes of cold therapy after 2 to 3 hours in a person's freezer at home. The thermotherapy device can also be prepared for heat therapy by being placed in a household microwave oven (45 seconds each side—approximate times). This device can also be prepared for heat therapy when placed in a water tight container and placed in a hydrocollator (electric boiler) for about an hour. Hydrocollators are commonly used in rehabilitation clinics to heat the common square or neck silica heat packs. This versatility of preparation offers convenient choices to the user.
It is a commonly accepted fact that water temperature above 98.6° F. (body temperature) is said to be hot. Water that is about 70° to 80° F. is considered cool. In addition, water at 55° F. and below is considered cold. On this basis, the thermotherapy device of the present invention will achieve the necessary temperatures that are used to define both heat and cold therapy. When using any type of heat or cold therapy, it is necessary to prepare and monitor the wearer. The wearer must always use insulation between the skin and contact surface of the device. With regard to the thermotherapy device of the present invention, a thick sock, such as an athletic sock should be worn to provide a more comfortable, safer thermotherapy. With further consideration to heat/cold therapy, Stillwell (1972) states that a minimal time of 20 minutes is physiologically sound for the duration of a heat treatment. Lehman (1982) states that the temperature must be elevated between 40° C. and 50° C. (104° F. to 113° F.) in order to be of therapeutic value. Below 40° C., heating is considered mild. While other experts may differ somewhat on what the appropriate times and temperatures for thermotherapy are, the thermotherapy device of the present invention will achieve the necessary levels of temperature for providing therapeutic heat and cold treatments. In addition, if the temperature increases too slowly, then the amount of heat added could be balanced out by the convective effect of cooler blood, thereby causing the effective therapeutic levels to be obtained.
The thermotherapy device of the present invention uses an existing technology that will heat or cool slowly and comfortably for the wearer with safety, also a paramount consideration. Other embodiments use a form of fastening so that the wearer has stability during ambulation/weight bearing activities. The thermotherapy device of the present invention uses three fastener straps that may be VELCRO® or another type of fastener as well. The function of the three adjustable straps is to increase or decrease surface contact between the foot and ankle against the boot. Explaining further into the background of the present invention, the polymer gel initially is a liquid substance which is poured into a mold. The mold is made of oak or plywood and measures 26 inches in length and 12 inches wide. There are two shapes carved into the mold. The two shapes are the sole and body of the device. Both of these shapes have dimples or concavities further tooled throughout the entire surfaces of the two shapes. These dimples or concavities measure ½″ to ¾″ deep. A scrim is placed on the back of the sole and body shapes while they are setting in the mold. The scrims are ⅛″ or less thick. They are made of cloth and provide a means of reinforcement to protect the two gel pieces from cracking. Once the gel sets, the sole and body gel shapes are pulled from the wooden mold. The ½″ to ¾″ dimples or concavities will form the soft dimples or nodules providing the THERMABUMP® design. The THERMABUMP® design provides a superior contact between the dorsal and plantar aspects of the metatarsal heads; the dorsal and plantar aspects of the tarsal bones; and the medial and lateral malleoli, which are the two boney protuberances we usually refer to as the ankle. The THERMABUMP® design is soft and pliable enough so that it will not cause compromise or cause discomfort to the wearer.
There are other devices which, we maintain, have certain disadvantages such as liquid or gel filled chambers that can leak. There are ice packs that, when frozen, become hard and brittle over a period of time. There are other devices which provide only partial coverage of the foot and ankle, as well. The thermotherapy device of the present invention is specifically designed for easy and convenient use. Also, the present invention envelops the entire foot/ankle complex which ensures consistent treatment every application. In spite of these prior arts, there remains a substantial necessity for a convenient, cost effective and thorough choice for heat/cold therapy treatment of the foot/ankle complex.